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Amicus Therapeutics Presents Positive Data Update From Phase 2 Extension Study of Amigal(TM) for Fabry Disease
Date:2/11/2010

CRANBURY, N.J., Feb. 11 /PRNewswire-FirstCall/ -- Amicus Therapeutics (Nasdaq: FOLD) announced today additional positive preliminary data from its ongoing Phase 2 extension study of its investigational drug Amigal™ (migalastat HCl) for Fabry disease at the Lysosomal Disease Network WORLD Symposium in Miami, Florida.  The Company also presented encouraging data from preclinical studies evaluating the combination of pharmacological chaperones and enzyme replacement therapy (ERT) for Fabry disease and Pompe disease as well as from preclinical studies examining the use of pharmacological chaperones for the treatment of Parkinson's disease.  

Phase 2 Extension Study Overview

Twenty-six subjects completed either 12 or 24 weeks of treatment with migalastat HCl during the initial Phase 2 studies and twenty-three subjects enrolled in a separate, voluntary long-term extension study designed to evaluate the long-term safety and efficacy of migalastat HCl.  Over the course of the initial Phase 2 and extension studies, fifteen subjects have been treated with migalastat HCl for approximately 2-3 years and eight subjects have been treated with migalastat HCl for more than 3 years.  Twenty-one subjects continue to receive treatment in the ongoing extension study.

Preliminary Data Update from Long-term Phase 2 Extension Study

During the course of the extension study, treatment with migalastat HCl has been generally well-tolerated, with no drug-related serious adverse events.  The most common adverse events were headache, arthralgia and diarrhea.  

Renal function is being evaluated by two measures in the extension study, estimated glomerular filtrat
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SOURCE Amicus Therapeutics
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